Lawsuits

According to a Bloomberg news report this week, Humira is at the center of another lawsuit because of related side effects. This suit involves a Tennessee man who claims that the popular arthritis drug led to a fungal infection that proved to be somewhat life threatening.

Abbott Laboratories, the manufacturer of Humira, is said to have filed a letter in 2010 to physicians which outlined the risk of fungal infection that may come with Humira use, according to the report. The problem with this is that Abbott may have known about the risks long before they issued proper warnings.

The news report states that the Tennessee man began using Humira in September 2008. Bloomberg news stated that around the same time, the US Food and Drug Administration required Abbott to warn physicians of the first fatal risks involved with Humira, including histoplasmosis.

The Bloomberg news claimed that the man took Humira in conjunction with methotrexate, a suppressant prescribed to numerous arthritis patients. The article also stated that Abbott is alleged to have known this information for nearly a year and half, as the drug was first marketed in early 2007.

Humira has been the subject of numerous lawsuits throughout the past couple years. As a major arthritis drug, Humira has been reported to increase the risk of numerous side effects besides fungal infection, including optic nerve damage, lymphoma, vision issues and other nerve damage. Abbott has consistently been the subject of lawsuits because of their alleged inability to keep awareness of the possible risks of Humira at a proper level.

Originally developed as a tumor blocking and biologic drug, Humira was released by Abbott in 2003 as a major treatment for arthritis patients. Before controversy in recent years, Humira had been approved to treat a number of other conditions as well. The article states that since Humira’s introduction in 2003, it’s been approved by the FDA to treat five other illnesses besides arthritis, including Chron’s disease

According to the news report, Humira is one of the most popular drugs in the world, totaling yearly sales around $6.55 billion. The article also states that research company EvaluatePharma is forecasting Humira to be the world’s most lucrative drug before the year 2016.

Humira, the major arthritis and Crohn’s disease drug from Abbott Laboratories, is facing litigation over a woman who’s alleging that vision problems and optic nerve damage have developed as a result of using the drug.

The use of Humira is alleged to have caused optic neuritis, which is an inflammation within the optic nerve. Because of this inflammation, there is the possibility of impairment to vision and other nerve issues, including more vision loss or multiple sclerosis.

Humira has been used as a biologic, or tumor blocking drug. Released by Abbott Laboratories in 2003 as an arthritis treatment, Humira has gone on to be approved for a number of other medical conditions. Major use has increased for treatment of Crohn’s Disease in recent years.

The New York woman complained that Abbott Laboratories dismissed any notion or risk of vision issues as a relation to their product. This came, even despite information that the drug could increase risks of nerve damage and optic neuritis.

After only a month using Humira in 2008, the woman began experiencing repeated headaches and pain in her eye. She then called the phone number that came along with Humira in the chance of any problems. The nurse on the Abbot hotline continued to say that the headaches and pain were in no way related to the use of Humira, suggesting she speak to another physician.

After experiencing bouts with blurry vision and black spots, the woman sought immediate emergency medical attention. Doctors found that there was optic neuritis from Humira in both eyes. Without the proper warning, the woman suffered long term vision impairment.

The case is largely based on the notion that as the manufacturer, Abbott should’ve been aware of the risks involved with Humira when the drug began to be marketed in 2007. Studies back to that time have detailed deterioration within the optic nerves involving both Remicade and Enbrel, two similar and competing drugs with Humira.

An important factor in the case is the fact that competing drugs in the same class as Humira show specific warnings of optic nerve damage with repeated use. Abbott is already the subject of multiple other cases of litigation involving lymphoma and nerve damage. In all other cases involving Abbott, both punitive and economic damages are being sought.

Heather Gillespie of Louisiana has filed the latest lawsuit against the birth control product Yaz. Ms. Gillespie states she experienced numerous pulmonary emboli as a result of taking Yaz.

Pulmonary emboli happen when a blood clot becomes wedged close to the lung. This in turn blocks the artery which supplies blood to the lung and can cause severe or fatal complications. Indications of pulmonary embolism include heart palpitations, chest pain, difficulty breathing, rapid breathing, increased heart rate, and unusually low blood pressure.

Yaz is a birth control pill that is manufactured and marketed by Bayer Corp., and the lawsuit is filed against them, as well as against Bayer Health Care Pharmaceuticals, Bayer Pharmaceuticals Corp, Bayer Healthcare, Bayer Schering Pharma AG, Berlex Laboratories, Berlex, and Bayer Healthcare AG. Berlex initially produced the birth control pill and was later bought out by Bayer.

The lawsuit alleges Ms. Gillespie took Yaz for less than a year and during this time suffered from numerous pulmonary blood clots which broke free and caused injury and damage to her body. This suit adds to the more than 1,100 other suits that have been filed in the U.S. against the makers of both Yaz and Yasmin. Both of these birth control pills contain drospirenone, which is the substance that is allegedly causing problems in women. Drospirenone, a fourth generation progestin, is only found in Yaz and Yasmin, as well as their generic counterparts.

In addition to pulmonary emboli, drospirenone is being blamed for deep vein thrombosis, heart attack, gallbladder disease, and stroke.

According to the Gillespie lawsuit filed in the New Orleans U.S. District Court, she is seeking undisclosed compensation for pain, mental anguish, suffering, physical disfigurement and impairment, medical expenses, court costs, and financial and earnings losses.

Federal lawsuits against Yaz and Yasmin are being combined into multidistrict litigation (MDL). The MDL is set for pretrial litigation in the Southern District of Illinois. State lawsuits against Yaz and Yasmin are being centralized in Pennsylvania and New Jersey. The lawsuits are based on the premise that the makers of Yaz and Yasmin inadequately warned that otherwise healthy young women could face an increased risk of serious health problems caused by Yasmin side effects.

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